Class I - Dangerous
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Compromised sterility due to breach of barrier
Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
Skytron, Div. The KMW Group
Class I - Dangerous
Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
Class I - Dangerous
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Class I - Dangerous
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
Covidien
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
Compromised sterility due to breach of barrier
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Natus Medical Incorporated
Class I - Dangerous
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
Class I - Dangerous
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Class I - Dangerous
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
Class I - Dangerous
Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.